Optimal Volume, Rate, and Interval of Bolus Nerve Catheters for Shoulder Surgery
Up-down Sequential Allocation Study to Determine the Optimal Volume, Rate, and Interval of Bolus of Ropivacaine 0.2% in Interscalene Continuous Nerve Catheters for Shoulder Surgery
The purpose of this study is to determine the ideal delivery of local anesthetics for pain control when using continuous interscalene peripheral nerve catheters for shoulder surgery.
The study will be conducted in three stages. In the first stage the ideal bolus volume of ropivacaine will be determined. In the second stage the optimal rate of delivery of the bolus (infusion rate) will be determined. Finally, once both the ideal volume and infusion rate has been determined, the optimal interval between boluses of local anesthetic will be determined.
연구 개요
상세 설명
The purpose of this study is to determine the ideal delivery of local anesthetics for postoperative analgesia when using continuous interscalene peripheral nerve catheters for shoulder surgery. New technology has emerged with electronic pumps that permit intermittent mandatory boluses of local anesthetic to be delivered in addition to continuous infusions. The pump would automatically deliver a bolus at a given interval, but would otherwise be idle for a period of time. This technology could improve the efficacy of local anesthetics, and thereby improve postoperative analgesia.
Continuous peripheral nerve catheters have been shown to improve pain control in several orthopedic surgical procedures when compared to opioids. However, it is not uncommon for patients to experience breakthrough pain in spite of a functional peripheral nerve block. Many times, this breakthrough pain can be managed with a bolus of local anesthetic administered by an anesthesia provider. Until recently, the vast majority of peripheral nerve catheter infusion pumps have only had the capability of providing a constant rate of local anesthetic administration. Newer technology allows for infusion pumps to deliver intermittent mandatory boluses of local anesthetic. This technique of local anesthetic administration has previously been evaluated with popliteal nerve blocks, but to our knowledge has never been evaluated for use with interscalene nerve catheters.
Currently, data would support the idea that a bolus of local anesthetic can improve analgesia with decreased side effects compared to a continuous infusion. However, there is little data evaluating the optimal volume of bolus, the optimal speed of delivery, or the optimal interval between local anesthetic boluses.
연구 유형
단계
- 4단계
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke Ambulatory Surgery Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female, ≥18 years of age
- Patients scheduled to undergo unilateral shoulder surgery at Duke University Medical Center, including arthroscopic rotator cuff repair, acromioplasty, hemiarthroplasty, and total shoulder replacement.
- American Society of Anesthesiology (ASA) Physical Class 1-3.
- BMI ≤40 kg/m2
Exclusion Criteria:
- Patients with a contraindication to placement of interscalene nerve block. This includes abnormal clotting, skin infection involving the neck, the presence of neurological disorders or cervical spine disease, contralateral phrenic nerve dysfunction, or moderate-severe COPD (FEV1<80% of normal values and/or FEV1/FVC < 0.70)
- Patients with chronic pain (pain existing for longer than 6 months), or taking chronic opioids (greater than 60 morphine equivalents per day) at time of surgery
- Contraindications to or known drug interactions with local anesthetics
- Patients who will be discharged home directly from PACU
- Planned administration of another investigational product or procedure during the subject's participation in this study.
- Patients who do not have the capacity to give legally effective consent
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
- Pregnant women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Volume of bolus
Ropivacaine 0.2% volume increased or decreased by 1ml based on previous patient experience.
If pain greater than or equal to 5/10 in the previous patient, the current patient will receive an increase in volume of bolus by 1ml.
If pain is less than 5/10 in the previous patient the current patient will receive a decrease in volume by 1ml.
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Change in administration of ropivacaine.
Rate, Volume and Interval of bolus altered.
다른 이름들:
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실험적: Rate of delivery of bolus
Ropivacaine 0.2% rate increased or decreased by 50ml/hr based on previous patient experience.
If pain greater than or equal to 5/10 in the previous patient at 30 minutes, the current patient will receive an increase in rate of bolus by 50ml/hr.
If the pain is less than 5/10 the rate will be decreased by 50ml/hr.
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Change in administration of ropivacaine.
Rate, Volume and Interval of bolus altered.
다른 이름들:
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실험적: Interval between bolus
Ropivacaine 0.2% interval increased or decreased by 1 hour based on previous patient experience.
If the previous patient received pain score of 2/10 at 2 hours then the current patient will have an interval of three hours.
If the pain is greater than 2/10, the interval will be shortened by 1 hour.
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Change in administration of ropivacaine.
Rate, Volume and Interval of bolus altered.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Optimal Volume of Ropivacaine 0.2% bolus via interscalene catheter
기간: 1 day
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Up-down sequential allocation alteration of volume to determine optimal volume of bolus
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1 day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Optimal Rate of Ropivacaine 0.2% administration bolus via interscalene cathter
기간: 1 day
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Up-down sequential allocation alteration of rate to determine optimal rate of bolus
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1 day
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Optimal Interval of Ropivacaine 0.2% administration of bolus via interscalene catheter
기간: 1 day
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Up-down sequential allocation alteration of interval to determine optimal interval of bolus
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1 day
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Joshua R Dooley, MD, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00072762
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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